Aflatoxin exposure in children age 6-12 years: a study protocol of a randomized comparative cross-sectional study in Kenya, East Africa.

BACKGROUND: Aflatoxins (AFs) are naturally occurring fungal metabolites produced by the Aspergilla species of fungi. The staple food grain, maize (Zea mays), is highly susceptible to AF contamination. In Kenya, contamination of maize supplies by AFs is a recognized public health problem which has resulted in over 600 human deaths. Human exposure to AFs can occur in utero, via breast milk, through weaning foods, and throughout an individual's lifetime. Recent epidemiological studies have shown that exposure to AFs in early life through diet is a contributing factor to immune suppression, micronutrient deficiency, possible vaccine interference, and impaired growth in children. However, these results remain inconsistent and inconclusive due to lack of randomized controlled studies. METHODS: A randomized school-based cross-sectional study was designed to study AF exposure levels and associated health effects in children between ages 6 and 12 years. Participants were recruited from primary schools within Siaya and Makueni Counties of Kenya, East Africa. The Joint Ethics Committee of the University of Nairobi and Kenyatta National Hospital in Kenya approved the research protocol and procedures for the study. Both parental consent and child assent were obtained before enrollment in the study. Parents were requested to provide household grain samples and fill out questionnaires detailing their sociodemographic information, household dietary patterns, farming practices, and knowledge of AF contamination. Blood samples were collected from children participants, and sera were prepared for analysis of AFB1-lysine which is one of the validated biomarkers for AF exposure. DISCUSSION: This protocol describes a school-based, cross-sectional study whose objective is to comparatively evaluate the role of AF exposure on adverse health outcomes in children. Specifically, effects of cumulative AF exposure on nutritional status, immune markers, and growth parameters will be assessed. TRIAL REGISTRATION: This study is not a clinical trial, rather a cross-sectional study aimed at providing baseline data on AF exposures in children who live in presumably high versus low AF exposure regions. Results from the study can be used to design interventions and/or prospective cohort studies aimed at studying adverse health effects associated with cumulative AF exposure through diets. The study reference number is P741/12/2017 and registered with KNH-UoN Ethics and Research Committee.